INNOVATIVE TECHNOLOGIES FOR HAZARDOUS WASTE SITE REMEDIATION AND MONITORING (SBIR/STTR) Release Date: August 29, 2001 RFA: RFA-ES-02-001 National Institute of Environmental Health Sciences (http://www.niehs.nih.gov) Letter of Intent Receipt Date: October 15, 2001 Application Receipt Date: November 20, 2001 PURPOSE The mission of the National Institute of Environmental Health Sciences (NIEHS) is to promote research that will ultimately reduce the burden of human illness and dysfunction from environmental causes. Complementary to this mission are the goals of the national Superfund Program, established by Congress in 1980 to: identify, uncontrolled hazardous wastes; characterize the impacts of hazardous waste sites and emergency releases on the surrounding environment (i.e. communities, ecological systems, and ambient air, soil, water); and, institute control or remediation approaches to minimize risk from exposure to these contaminants. With the 1980 passage of the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), better known as Superfund, it soon became clear that the strategies for the cleanup of Superfund sites and the technologies available to implement these cleanups, were inadequate to address the magnitude and complexity of the problem. In 1986, six years after the CERCLA was enacted, Congress authorized NIEHS to implement a university-based program of basic research and training grants. The intent was to improve the ability to identify, assess, and evaluate the potential health effects of exposure to hazardous waste and to develop innovative chemical, physical and biological technologies for remediating sites contaminated by hazardous substances. The assignment of this Program, the Hazardous Substances Research and Training program [Superfund Basic Research Program (SBRP)], to the NIEHS underscored an emphasis on human health effects assessment, evaluation and prevention. However, NIEHS was provided latitude to support non-traditional NIH research areas such as fate and transport and remediation strategies for environmental contaminants. NIEHS has implemented this program by supporting coordinated multiproject, multidisciplinary university-based programs that link biomedical research with related engineering, hydrogeologic and ecologic research. A component of this multidisciplinary approach has been the development of innovative remediation technologies that limit and/or prevent exposure. The Superfund Basic Research Program has been very successful in developing innovative remediation technologies through support of basic science (http://www-apps.niehs.nih.gov/sbrp/). For example innovative approaches being developed in biotechnology and bioengineering provide exciting opportunities for the development of novel remediation strategies. However, there is a need to ensure that these processes and others are further developed, field tested and applied to real world situations. This initiative is designed to foster the commercialization of technologies, products and devices developed by the SBRP and others. An intent of this solicitation is to develop products emanating from the science supported by the SBRP that is relevant to the clean-up and monitoring of hazardous substances. The Small Business Innovative Research /Small Business Technology Transfer Research (SBIR/STTR) program is ideally suited to support these demonstration commercialization opportunities. This RFA provides a flexible system within the SBIR/STTR program that allows for the development of products and devices for remediation and monitoring of hazardous waste sites. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Innovative Technologies for Hazardous Waste Site Remediation and Monitoring, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Eligibility requirements are described in the Omnibus SBIR Solicitation. Each organization submitting an SBIR/STTR grant application must qualify as a small business concern in accordance with the definition given in Section III of the Omnibus SBIR Solicitation (http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf). MECHANISM OF SUPPORT This RFA invites grant applications for SBIR/STTR projects with award duration and amounts greater than those routinely allowed under the SBIR/STTR program. This RFA must be read in conjunction with the Omnibus Solicitation of the Public Health Service (Omnibus Solicitation) for Phase I SBIR/STTR Grant Applications (PHS 2001-2). The information in these documents also applies to applications in response to this RFA. The NIH has announced that applicants may request a larger budget and period of support if necessary for completion of the project. See NIH Guide for Grants and Contracts, February 13, 1998 at: http://grants.nih.gov/grants/guide/notice-files/not98-014.html This RFA is a one-time solicitation. Responsibility for the planning, direction and execution of the proposed project will be solely that of the applicant. Awards will be administered under NIH grants policy stated in the NIH Grants Policy Statement of March 2001 (http://grants.nih.gov/grants/policy/nihgps_2001/). A. INDIVIDUAL PHASE I APPLICATIONS. Phase I applications in response to this RFA will be funded as Phase I SBIR Grants (R43) and STTR Grants (R41) with modifications as described below. Applications for Phase I grants should be prepared using the revised PHS 398 Instructions and fillable Forms (rev 05/01) which are available on the Internet at http://grants.nih.gov/grants/funding/phs398/phs398.html. Specific SBIR instructions are located in Chapter VI of the PHS 398. Because the length of time and cost of research involving development and evaluation of remediation technologies may exceed that routinely awarded for SBIR/STTR grants, the NIEHS will entertain well-justified Phase I applications for an SBIR/STTR award with a project period up to two years and a budget not to exceed a total cost of $200,000 per year. Consultant and contractual costs associated with Phase I: The total amount of all consultant costs and contractual costs normally may not exceed 33 percent of the total costs requested for Phase I SBIR applications. However, the NIEHS will entertain well-justified Phase I applications for an SBIR award with greater than 33 percent contractual costs when those costs are necessary to support development and evaluation of a remediation or monitoring technology. Specific page limitations for Phase I applications apply (see PHS 398). B. INDIVIDUAL PHASE II APPLICATIONS. Phase II applications will not be accepted in response to this RFA unless they are part of the FAST-TRACK. This solicitation is only for Phase I or FAST-TRACK SBIR/STTR applications. A separate announcement for Phase II applications that result from funded Phase I studies under this RFA will be developed at a later time. C. FAST-TRACK APPLICATIONS. Applications may be submitted for the FAST-TRACK review option. Information on the FAST-TRACK process may be found in Section VI-B of the PHS 398 at: http://grants.nih.gov/grants/funding/phs398/phs398.html. To be eligible for the FAST-TRACK option, the Phase I SBIR application must include well defined quantifiable milestones that will be used to judge the success of the proposed research, as well as a credible plan to apply the selected technology in a pilot study of interest to test the feasibility for site remediation or monitoring technology for the Phase II R44 application. The FAST-TRACK must have a section labeled Milestones at the end of the Research Plan Phase I. This section must include well-defined quantifiable milestones for completion of Phase I, a discussion of the suitability of the proposed milestones for assessing the success in Phase I, and a discussion of the implications of successful completion of these milestones on the proposed Phase II. In addition, Fast-Track applications must include a concise Product Development Plan (limited to ten pages). Label this section clearly and include it in Section J of the Phase II Research Plan. Applications submitted through the FAST-TRACK option are subject to the same total cost limits per year as when submitted outside of the FAST-TRACK option: Phase I R43, not to exceed $200,000 per year total direct costs excluding subcontractor indirect costs; Phase II normally not to exceed $500,000 total costs per year. The total duration (Phase I plus Phase II applications) cannot exceed four years. In any case, the Phase I application cannot exceed two years duration. FUNDS AVAILABLE The NIEHS intends to commit up to $1.5 million in FY 2002 from the Superfund Basic Research Program allocation to fund four to eight new awards in response to this RFA. The number of awards will be contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. BACKGROUND The goal of this proposed research initiative is to stimulate the development of innovative remediation products to clean-up hazardous substances commonly found at Superfund sites. From a regulatory perspective, protection of human health, ecological health and the environment depends upon both limiting exposure and preventing exposures, where possible. Prevention strategies to minimize the exposure to a population, human or wildlife, require the development and application of appropriate remediation technologies. Many Superfund hazardous waste sites contain a large number of diverse toxic chemicals. Many contain synthetic chemicals having novel structures that are rarely found in nature; hence they are degraded slowly by naturally occurring organisms. Through the multidisciplinary nature of the SBRP, both basic and applied research has been supported leading to the development of innovative remediation strategies and technologies that are tackling these difficult contamination scenarios. Research supported through this program has focused on bioremediation, including phytoremediation and physical and chemical methods to remediate contaminants from environmental media. For example, bioremediation strategies have included the use of microbes and engineered microbes, to reduce or eliminate the toxicity of hazardous substances. Phytoremediation strategies are being developed to remove volatile organics and metals from aquifers and sediments. Physical/chemical methods such as novel sorbents, supercritical fluid technologies, and electrochemical methods are being developed to reduce the burden of exposure to hazardous substances. Although the SBRP has provided long-term investments in basic research, it is critical that the research findings be translated into useful applications directed toward attenuation and prevention of exposure. There is a continued need for the development and validation of newer and cheaper approaches to remove hazardous substances from environmental media such as soil, sediment and aquifers. In addition, there is a need to develop monitoring strategies to assess the amount and extent of contaminants at a site or monitor the effectiveness of a remediation technology in both the short and long term. This solicitation provides a mechanism for the potential commercialization of effective remediation technologies. RESEARCH OBJECTIVES This solicitation is in support of: - Product development of innovative treatment technologies - Novel monitoring and measurement devices - Refinement of treatment technologies that are currently under development Approaches may take advantage of state-of-the-art molecular, chemical or physical treatment, biotechnology, engineering or bioengineering methods. Research may include any or all of the phases involved in taking an innovative technology to commercialization. For example, bench scale studies, field- testing, pilot-scale demonstration, and demonstration research are all appropriate for this solicitation. The research plan should also allow for feasibility studies, evaluation of the performance of the technology or product and a cost assessment. Applicants are encouraged to partner with existing grantees that have developed innovative methods that are ready for scale-up research. (The SBRP maintains a complete website describing all projects being supported by the program: http://www-apps.niehs.nih.gov/sbrp/Program2000/programs00.cfm) For the purposes of this RFA, the appropriate environmental media for clean up are soil, sediments and aquifers. The appropriate chemicals for remediation are: - Hazardous substances found with some frequency at Superfund sites. - Hazardous breakdown products of such substances formed in environmental media. - Mixtures of substances or breakdown products of such substances found with some frequency at Superfund sites. Note also that the applicant may refer to the Web site: http://www-apps.niehs.nih.gov/sbrp/descrip/respri.cfm to obtain information on hazardous substances that are relevant to Superfund and to the Environmental Protection Agency (EPA) and the Agency for Toxic Substances and Disease Registry (ATSDR). Approaches appropriate for this initiative include but are not limited to the following: o Bioremediation approaches. This could include the development and use of genetically engineered microbes, biosurfactants, and bioreactors. o Biodegradation approaches. Specifically there is interest in recalcitrant chemicals, simple and complex mixtures, and metals. o Sequestration approaches. This could include methods that change the valence state of metals rendering then less toxic. o Phytoremediation strategies. This could include development of plant strains or use of genetically engineered higher plant species to remediate toxic waste sites. o Physical/chemical methods. Some examples of approaches that may be considered include development of functional nano-structures, electrochemical methods, supercritical fluid extraction, photocatalytic processes, thermal treatment and filtration-based methods. o Mixed technology approaches that combine biological, chemical and physical treatments. o Remediation methods for metals and metal-organic mixtures (e.g., Arsenic, Mercury, Cadmiun, Manganese). There is specific interest in innovative biological or biophysical approaches for remediating metals found in high concentrations or widely dispersed in soils and sediments. o Real-time monitors. For example, the development of an in-line detector to monitor the performance of a remediation technology for the long-term assessment of the effectiveness of remedial actions. o Tools for assessing the long-term reliability of remediation technologies o Instruments to characterize hazardous waste sites. This could include biosensors, immuno-based assays or other field-ready instruments that measure chemical contaminants. o Devices to detect and measure hazardous substances. For example, there is interest in the detection of organics in non-aqueous phase liquids and dense non-aqueous phase liquids in the subsurface. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the Inclusion of Children as Participants in Research Involving Human Subjects that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in a NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at: http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIEHS staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the letter of intent receipt date listed to: Linda Bass, Ph.D. Scientific Review Administrator Scientific Review Branch Office of Program Operations Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD EC-30 79 TW Alexander Drive, Building 4401 Research Triangle Park, NC 27709 Phone: (919) 541-1307 Fax: (919) 541-2503 E-mail: bass@niehs.nih.gov APPLICATION PROCEDURES Applications in response to this RFA should be submitted using the 5/2001 revised PHS 398 Application Instructions and new interactive, fillable PDF Forms. See http://grants.nih.gov/grants/forms.htm for links to these forms. Specific instructions for preparing SBIR applications may be found in Section VI of the PHS 398. For further assistance contact GrantsInfo, telephone 301/710-0267, Email: GrantsInfo@nih.gov Applicants should follow the instructions for SBIR Phase I submission with the modifications as noted in this RFA. This RFA must be read in conjunction with the OMNIBUS SOLICITATION OF THE PUBLIC HEALTH SERVICE FOR SMALL BUSINESS INNOVATION RESEARCH GRANT (SBIR) APPLICATIONS (PHS 2001-2). All of the instructions within the Omnibus Solicitations apply with the following exceptions: - Special receipt date - Additional award considerations - Increased award and amount of duration - Use of the PHS 398 Instructions and Forms Applications received in response to this RFA are to be prepared as described in the PHS 398. Eligibility requirements to participate in the SBIR Program are described in the Omnibus Solicitation, available electronically through the NIH, Office of Extramural Research Small Business Funding Opportunities at http://grants.nih.gov/grants/funding/sbir.htm. Helpful information in preparation of the application can be obtained at http://grants.nih.gov/grants/funding/sbir_policy.htm SBIR/STTR projects submitted in response to this RFA must contain a Phase I feasibility segment that must be successful prior to a Phase II award. Applications can be submitted for Phase I support, or as a combined Phase I and II (FAST-TRACK). Projects may be presented for SBIR/STTR support at all stages of remediation technology development or development of instruments and tools for monitoring. Projects will be evaluated on overall innovation and success potential. Larger budgets could be considered for Phase I if required for conduct of the research and appropriately justified in the application. The second year of support will be contingent upon NIEHS programmatic evaluation to ensure that the investigators are accomplishing milestones and time lines presented in the original application. FAST-TRACK: Due to the complex nature of the development and validation of innovative remediation technologies, it is recommended that only well-defined and more advanced projects be proposed for support through this mechanism. FAST-TRACK applications must specify clear, measurable goals for Phase I that should be achieved prior to Phase II funding. In addition, Fast-Track applications must include a concise Product Development Plan (limited to ten pages). Label this section clearly and include it in Section J of the Phase II Research Plan. Failure to provide measurable goals in the Phase I application and/or sufficient detail in the Phase II application may be sufficient reason for the peer review committee to exclude the Phase II from consideration. Special provisions described in this RFA pertaining to Phase I and Phase II also apply to FAST-TRACK applications. The RFA label available in the PHS 398 (rev. 5/01) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label included below For application in response to SBIR/STTR. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. For purposes of identification and processing, the title and number of this RFA must be shown in item 2 on the face page of the SBIR/STTR Phase I applications. Follow the mailing instructions in the Omnibus Solicitation for Phase I or FAST-TRACK applications. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the applications must be sent to: Linda Bass, Ph.D. Scientific Review Administrator Scientific Review Branch Office of Program Operations Division of Extramural Research and Training National Institute of Environmental Health Sciences 79 T.W. Alexander Drive, Building 4401, Room 116 Research Triangle Park, NC 27709 Phone: (91) 541-1307 Fax: (919) 541-2503 E-mail: bass@niehs.nih.gov Applications must be RECEIVED BY the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIEHS. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIEHS in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score and receive a second level review by the National Advisory Environmental Health Sciences Council. REVIEW CRITERIA Review criteria are described in the PHS 398 and available on the web at the following URL address: http://grants.nih.gov/grants/funding/phs398/phs398.html Additional review criteria are that the proposal must produce a remediation or monitoring technology that is relevant to clean-up issues faced by Superfund sites and that the application must address the evaluation and validation of the method. The Phase I application should specify clear, measurable goals (milestones) that should be achieved prior to initiating Phase II. The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: Does this study address an important problem in the remediation or monitoring of hazardous substances? Does the proposed project have commercial potential to lead to a marketable product or process? What may be the anticipated commercial and societal benefits of the proposed activity? If the aims of the application are achieved, how will environmental clean up or monitoring be advanced? Does the proposal lead to enabling technologies (e.g., instrumentation, software) for further discoveries? Will the technology have a competitive advantage over existing/alternate technologies that can meet the market needs? To what degree does the product rely on state-of-the- art technology? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Is the proposed plan a sound approach for establishing technical and commercial feasibility? Does the applicant acknowledge potential problem areas and consider alternative tactics? What is the time frame for developing the proposed technologies and the suitability of this time frame for meeting research needs? How easy will it be to use the proposed technology? Are the plans for the proposed technology, its integration as an effective solution for implementation and dissemination adequate? If partnerships are proposed, how will they facilitate the development and integration of the product? For FAST-TRACK applications - How appropriate are the proposed milestones against which to evaluate the demonstration of feasibility for transition to the Phase II application. (3) Innovation: Does the project apply novel concepts, approaches or method? Does the project challenge existing paradigms or develop new methodologies or technologies? Are the aims original and innovative? What is the throughput and cost effectiveness of the proposed technology? What additional uses can be projected for the proposed technology? (4) Investigator: Is the Principal Investigator capable of coordinating and managing the proposed SBIR/STTR? Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers, including consultants and subcontractors (if any)? Are the relationships of the key personnel to the small business and to other institutions appropriate for the work proposed? (5) Environment: Is there sufficient access to resources (e.g., equipment, facilities)? Does the scientific and technical environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL CONSIDERATIONS In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research. o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project(s) proposed in the application. SCHEDULE Letter of Intent Receipt Date: October 15, 2001 Application Receipt Date: November 20, 2001 Council Review: May 2002 Earliest Anticipated Start Date: July 2002 AWARD CRITERIA The following will be considered when making funding decisions: quality of the proposed project as determined by peer review, program balance among research areas of the announcement, the availability of funds, and the commercialization status where the small business concern has received more than 15 Phase II awards in the prior five fiscal years, if applicable (see this application requirement under Prior SBIR Phase II Awards found in the Introduction and Application Instructions potion of the Omnibus Solicitation). INQUIRIES Inquiries concerning this RFA are encouraged. Potential applicants are strongly encouraged to contact program staff for pre-application guidance and/or for more specific information on the research topics described in this RFA. They are also encouraged to read the advice and information on SBIR programs located on the Internet at: http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf Direct inquiries regarding programmatic issues to: Ms. Beth Anderson Program Analyst Office of Program Development Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 111 T.W. Alexander Drive, MD EC-27 Research Triangle Park, NC 27709 Telephone: (919) 541-4481 Fax: (919) 541-4937 E-mail: tainer@niehs.nih.gov or Claudia Thompson, Ph.D. Scientific Program Administrator Office of Program Development Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 111 T.W. Alexander Drive, MD EC-21 Research Triangle Park, NC 27709 Telephone: (919) 541-4638 Fax: (919) 316-4606 E-mail: thompso1@niehs.nih.gov Direct inquiries regarding review issues to: Linda Bass, Ph.D. Scientific Review Administrator Scientific Review Branch Office of Program Operations National Institute of Environmental Health Sciences P.O. Box 12233 111 T.W. Alexander Drive, MD EC-02 Research Triangle Park, NC 27709 Telephone: (919) 541-1307 Fax: (919) 541-2503 E-mail: bass@niehs.nih.gov Direct inquiries regarding fiscal matters to: Ms. Carolyn Winters Grants Management Specialist Grants Management Branch Office of Program Operations National Institute of Environmental Health Sciences PO Box 12233 111 T.W. Alexander Drive, MD EC-22 Research Triangle Park, NC 27709 Telephone: (919) 541-7823 Fax: (919) 541-2860 E-mail: winters@niehs.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.113, 93.115 and 95.143 (NIEHS Superfund Hazardous Substances Basic Research and Education Grant Program). Awards will be made under authority of the Superfund Amendments and Reauthorization Act of 1986, Title 1, Section III, and Title II, Section 209 (Public Law 99-499); and are made under authorization of sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR Part 52 and 45 Part 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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